BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3151907 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05588
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    October 14, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). A 5076-52 IMPLANTABLE PACING LEAD. (B)(6) IMPLANTED: 2006. A D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2012. A 0185 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2006.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253286 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R